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Candidate Details
Name :
Eileen Hulambukie
Qualification :
Regulatory/ Quality Specialist
Industry :
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Candidate ID:
EH159
This candidate has been hired.

Regulatory/ Quality Specialist

About our Client

Regulatory/ Quality Specialist with a Master’s degree in Pharmaceutical Science from the University of Auckland, experienced in medical product compliance. A skilled communicator and presenter, adept at liaising with international organisations associated with public health and regulation of medical products such as WHO, APEC and Therapeutic Goods Administration, Australia. Enjoys collaboration, teamwork, training and mentoring others.  A good understanding of NZ culture through having studied and lived inAuckland between 2018 and 2020.

Achievements

Professional Experience

Technical Officer – Biotech Medicines and Medical Devices

Dec 2020 – present, & Dec 2012 –June 2019.

Note: between July 2018 and Dec 2020 I was a full-time student at the University of Auckland

Overview: Review quality and technical data and provide specialist reports and recommendations on granting of market approvals for medical products for the country

• Consultation meetings with clients and collect, review, approve and register applications for medical products from competent suppliers

• Review quality, safety and efficacy/effectiveness data for medical products

• Prepare reviews and recommendations for marketing authorization on medical products

• Provide technical advice to medical product suppliers (applicants) and other health entities and professionals

• Conduct monthly training and awareness on risk-communication and benefits of covid-19 vaccines and other medical products to health care workers throughout the country.

• Initiate, develop and provide feedbacks on technical documentations such as guidelines, SOPs etc.

• Contribute to revising medicines law (Medicines and Cosmetic Act 1999)

• Participates in in-country and overseas trainings, workshops, symposiums and conferences

• Virtually attend quarterly (and ad-hoc)engagements with Therapeutic Goods Administration Australia, to review medical products

• Provide technical advice to medicines quality control laboratory on standards, procedures and analytical tests.

Accomplishments:

• Reviewed and provided recommendations for all medical products procured through the government procurement system resulting in zero major quality issues for medical products supplied through the designated government procurement process

• Marketing authorisation granted for more than20 new medical products in Papua New Guinea

• Provided report and recommendations for approval for three Covid-19 vaccines in the country

• Trained more than one thousand healthcare workers in the country about the risk communication and approval of Covid 19vaccines, and trained and mentored more than 100 intern pharmacists

Hospital Pharmacist, Nov 2011 – Aug 2012

• Dispensed medications to outpatients as per prescriptions and issued medications to in-patients,

• Provided professional advice to health professionals and patients

• Accompanied medical practitioners to check and confirm drug sheets for in-patients

 

Lead Pharmacist, 2006 – Sept 2011

• Provided oversight and coordinate sale and marketing of medical products

Pharmacy Product Manager, 2004– 2006

• Stock and inventory management of medical products and reporting to Multichem New Zealand

Education

Master of Health Sciences, Pharmacology and Pharmaceutical Science (July 2019 - Dec 2020)

Postgraduate Diploma in Health Sciences with Merit in Pharmaceutical Science (July 2018 – Nov 2019)

• Bachelor of Pharmacy (2003)

• Diploma in Pharmacy Technology (2001)

 

Professional Development

• 2022 SCH APEC Medical Device COE training and APEC Round Table Dialogue on Global Regulatory Convergence on Medical Devices and Digital Health Technologies, 7th – 10th November, 2022

• Multi-Regional Clinical Trial and Good Clinical Practice, Virtual Workshop, 14th – 30 June 2021

• PMDA-ATC & U.S. FDA Paediatric Review Seminar, 11th – 14th June 2018

• Medical Device Vigilance Workshop Seoul, 14th – 19th September 2017

• Good Manufacturing Practice workshop on Risk Based Approach, 10th - 14th July 2017

• Pharmaceutical Quality by Design: A Risk Based Approach, National Institute of Pharmaceutical Education and Research, 26th October- 05th November 2015

• Standard and Laboratory Quality Control of Reproductive Health products Workshop, 18th – 22nd February 2013

Interests

Skills

• Knowledge of International Regulatory Guidance documents such as International Conference of Harmonisation (ICH) for medicinal products, International Medical Device Regulatory Forum (IMDRF), common technical documentations (CTD) format for registration of medicinal products

• Experience with quality management systems and familiar with Pharmacopoeia and ISO standards, drug discovery, drug development and market approval process

• Pharmaceutical formulation development parameters and Pharmaceutical risk management

• Analytical and bio analytical techniques such asHPLC, UV Spectrometry, texture analyser, Rheometer  

• Quality assurance and control (document and process controls)

• Critical thinking, research, scientific data analysis and technical report writing

Technical Skills

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